Regulatory Affairs Senior Manager

A global pharmaceutical company, based in Uxbridge, is currently looking for a Senior Regulatory Affairs Manager to join their team.

You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take pride in working to the highest standards, passionate about delivering excellence and focused on sharing regulatory best practices and guidance throughout the wider business.

Working with the regulatory team (and core stakeholders across multiple areas), your role will be to operate as a Regulatory Lead, providing centralized regulatory strategy and guidance across the region and ensuring that regulatory deadlines and approvals are achieved.

Responsibilities:

1. Develop, contribute, and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
2. Contribute regulatory guidance in order to enhance product development.
3. As the regulatory lead, sit with the wider project team, providing guidance on how regulatory strategy should be implemented.
4. Ensure that product development is aligned with the company's business model as well as global regulatory requirements.
5. Act as a point of contact between the company and regulatory agencies while pertaining important information.

Requirements:

1. Proven experience as a Regulatory Lead managing at least 1 product end-to-end lifecycle.
2. Clear demonstration of experience in developing centralized regulatory plans and strategy.
3. Strong communication and stakeholder management experience, with evidence of working in project teams where you have guided/advised on the implementation of your strategy/regulatory plan.
4. Previous experience in Regulatory Affairs, particularly within the pharmaceutical industry.
5. Centralized Regulatory Affairs experience.
6. Strong strategic experience within Regulatory Affairs.
7. Exposure to Regulatory Affairs full cycle and submissions procedures such as CTA, PIPs, ODDs, and MAAs is advantageous.
8. Exposure to Regulatory Affairs legislation and procedures.
9. Strong communication and interpersonal skills.

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed, or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.